Technology-assisted Collaborative Care Program for Depressed Patients With Chronic Disease at Primary Care
A Collaborative, Computer-assisted, Psycho-educational Intervention for Depressed Patients With Chronic Disease at Primary Care
1 other identifier
interventional
359
1 country
1
Brief Summary
Background: depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile. Methods: two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item \[PHQ-9\] scores ≥ 15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at three, six, and twelve months after enrollment. The primary outcome will be depression improvement at six months, defined as ≥ 50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Sep 2019
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 6, 2023
December 1, 2023
3.3 years
October 21, 2020
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression change
Defined as a 50% reduction in a participant's Patient Health Questionnaire-9 Item (PHQ-9) score compared to the baseline. The PHQ-9 minimum and maximum values are 0 and 27 points. Higher scores mean worse outcomes.
Even though the primary outcome is taken at six-month follow-up, this measure will also be reported at three- and twelve-month follow-up.
Secondary Outcomes (6)
Proportion of patients who change their depressive status
Three-, six-, and twelve-month follow-up.
Health-related quality of life
Three-, six-, and twelve-month follow-up.
Social solving problem skills
Three-, six-, and twelve-month follow-up.
Proportion of participants with change in blood pressure
Three-, six-, and twelve-month follow-up.
Ad-hoc questionnaire for the assessment of the acceptability of depression treatment
Three-, six-, and twelve-month follow-up.
- +1 more secondary outcomes
Other Outcomes (1)
Utilization of health care services
Three-, six-, and twelve-month follow-up.
Study Arms (2)
"Me cuido y me siento mejor"
EXPERIMENTALPatients in the primary care clinics assigned to the intervention will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists; structured telephone calls by social worker to monitor clinical progress and treatment adherence; usual medical care for chronic diseases; and access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. Study therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care.
Enhanced Usual Treatment
ACTIVE COMPARATORThe patients in the primary care clinics assigned to the comparator will receive the usual treatment for depression and their physical conditions -all the guaranteed interventions for people with depression, hypertension, and/or diabetes in primary care, according to the Clinical Guidelines for the Treatment of Depression- and their associated basket of health benefits included in the Regime of Explicit Health Care Guarantees. They will have access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles.
Interventions
A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension.
Eligibility Criteria
You may qualify if:
- Age 18 or older.
- Enrolled in the Cardiovascular Health Program (i.e. currently receiving treatment for diabetes and/or hypertension) at the study primary care clinics.
- Patient Health Questionnaire-9 Item (PHQ-9) score ≥ 15.
- Signed informed consent.
You may not qualify if:
- Functional illiteracy (i.e., patients unable to read and comprehend written information, such as the study questionnaires or written informed consent).
- Significant visual and/or auditive impairments (i.e., such as those imposing a serious difficulty to respond the study questionnaires or written informed consent).
- Pregnancy or breastfeeding.
- Cognitive impairment - ineligible patients would give a negative answer to questions "What year is it?" and "Where are we (place/address)?".
- In treatment for bipolar and/or psychotic disorder.
- Current psychological treatment for depression.
- High risk of developing alcohol/substance abuse problems, according to an Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score ≥ 27.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dirección de Salud Municipal I. Municipalidad de El Bosque
Santiago, Chile
Related Publications (1)
Rojas G, Martinez P, Guajardo V, Campos S, Herrera P, Vohringer PA, Gomez V, Szabo W, Araya R. A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial. BMC Psychiatry. 2021 Aug 21;21(1):418. doi: 10.1186/s12888-021-03380-2.
PMID: 34419010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Graciela Rojas
University of Chile
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 3, 2020
Study Start
September 3, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share